External fixators are widely used for the treatment of bone fractures or for joining together two or more bone fragments. Known fixators comprise bone screws which are inserted in the bones and use external devices such as fixation clamps, fixation bars, rings, etc., that allow the creation of a rigid structure able to hold together the bone fragments in the desired position until completely healed.
These external fixators have the advantage of ensuring strength and stability owing, among other things, to the use of bone screws which penetrate into the bones at a sufficient depth; in particular, these screws pass through the bone cortex in two points so as to provide a flexurally resistant fastening.
However, the use of bi-cortical screws may be excessively invasive for patients in critical conditions, who for example have multiple fractures along with, in some case, extensive wounds and/or contusions. In particular the time devoted to checking the tip which emerges from the second cortex may be critical.
Also, with particular reference to the reduction of fractures in long bones, the aforementioned bi-cortical screws pass through the medullary cavity, which makes it impossible to simultaneously insert a medullary nail, which is particularly suitable for the treatment of certain types of trauma.
Moreover, the surgical implant of a definitive fixator of the aforementioned type requires time and suitable facilities and is not always compatible with the unforeseen circumstances where rapid intervention is required; for example, it is relatively difficult to perform the implant of such an external fixator in the context of a field hospital or in any case under environmental conditions where sterility is not guaranteed and where the fracture must be treated as a matter of emergency.
In order to meet these specific needs, external fixators of a provisional nature have been developed that, in addition to having a structure which is generally slimmer and lighter, use unicortical screws or unicortical pins for the attachment to the bone, i.e. that have been designed to be screwed in superficially so that they are attached to a single bone cortex only.
The unicortical pin undoubtedly represents a less invasive fixation system than conventional bone screws; moreover, owing to its limited penetration, the pin does not reach the medullary cavity of the bone, thus avoiding the risk of unwanted infections.
On the other hand, however, owing to its limited stability—due mainly to the fact that it passes through one cortex only, which means that flexural strength is limited—this type of screw is not widely used in external fixation applications.
It would instead be desirable to be able to use an external fixator, which has the advantages of stability and strength typical of provisional fixation systems, and to combine it with the advantages of ease of application, lightness and limited invasiveness that are instead typical of systems that use unicortical pins.
The technical problem forming the basis of the present disclosure is therefore to devise a locking device for unicortical pins to be associated with external fixators, which is able to create a structure sufficiently rigid for it to withstand the external loads acting on it, so as to allow the formation of external fixators that are extremely flexible, but that at the same time have that degree of structural rigidity that typically distinguishes external fixation systems.
The device should have an optimum performance, under traction and compression, of the tip in the cortex of the bone and should eliminate, as far as possible, the flexural stresses acting on the shank of the single screw.